Covid 19 Clinical Trials

	Name (Synonyms)	Correlation
drug1132	Hydroxychloroquine, lopinavir/ritonavir or azithromycin and placebo (standard therapy) Wiki	1.00
drug1706	Oseltamivir Wiki	0.41
drug262	Azithromycin Wiki	0.17
drug1086	Hydroxychloroquine Wiki	0.10

Correlated MeSH Terms (4)

	Name (Synonyms)	Correlation
D013577	Syndrome NIH	0.11
D055371	Acute Lung Injury NIH	0.10
D012127	Respiratory Distress Syndrome, Newborn NIH	0.10
D012128	Respiratory Distress Syndrome, Adult NIH	0.09

Correlated HPO Terms (0)

	Name (Synonyms)	Correlation

There is one clinical trial.

Clinical Trials

1 Safety and Efficacy of Intravenous Infusion of Wharton's Jelly Derived Mesenchymal Stem Cell Plus Standard Therapy for the Treatment of Patients With Acute Respiratory Distress Syndrome Diagnosis Due to COVID 19: A Randomized Controlled Trial

Recent COVID 19 pandemic has overwhelmed health services all around the world, and humanity has yet to find a cure or a vaccine for the treatment of patients, mainly the severe ones, who pose a therapeutic challenge to healthcare professionals given the paucity of information we have regarding SARS-CoV-2 pathogenesis. Recently, reports mainly from China from patients treated with mesenchymal stem cells have shown promise in accelerating recovery, even in the critically ill and the therapy has sustained an increase in research because of it's powerful immunomodulatory effects, making it and interesting alternative in patients with lung and systemic inflammation. These effects could help treat a lot of patients and improve their outcomes, reason why phase I/II studies are needed to show their safety and experimental efficacy.

NCT04390152 Acute Respiratory Distress Syndrome Drug: Wharton's jelly derived Mesenchymal stem cells. Drug: Hydroxychloroquine, lopinavir/ritonavir or azithromycin and placebo (standard therapy)

MeSH:Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Syndrome

Primary Outcomes

Description: Evaluation of efficacy of WJ-MSC defined by mortality at 28 days of application.

Measure: Intergroup mortality difference with treatment

Time: 28 days.

Secondary Outcomes

Description: Safety evaluation of WJ-MSC describing and comparing incidence, type and severity of adverse events in both groups.

Measure: Number of patients with treatment related adverse events

Time: 6 months.

Description: Evaluation of the effect of WJ-MSC in the time of mechanical ventilation compared between the two groups, as prolonged mechanical ventilation days are associated with higher complication risks as pneumonia, tracheostomy and death.

Measure: Difference in days of mechanical ventilation between groups

Time: From ICU admission to 180 days.

Description: Evaluation of the effect of WJ-MSC in the time of hospitalization between the two groups as a measure of efficacy.

Measure: Median reduction of days of hospitalization

Time: From hospital admission to 180 days.

Description: Evaluation of the effect of WJ-MSC in the time of oxygen needs compared between the two groups as a measure of efficacy.

Measure: Median reduction of days of oxygen needs

Time: From hospital admission to 180 days.

Description: "Sequential Organ Failure Assessment" (SOFA) score is a tool used to determine the beginning and evolution of multiorgan failure, ranging from 0 to 24, being 24 the worst scenario. It has been proven useful as an outcome predictor of mortality and ICU stay. The result is the addition of the evaluation of each organ or system. Effect of WJ-MSC in the SOFA score will be compared between the two groups.

Measure: Difference between "Sequential Organ Failure Assessment" score between groups

Time: Baseline to 7 days

Description: Murray score is a tool used to classify lung injury. 0 = no lung injury, 0.1-2.5, mild to moderate lund injury, >2.5 Acute respiratory distress syndrome. The effect of WJ-MSC in the Murray score will be compared between the two groups.

Measure: Difference between median Murray score between groups

Time: Baseline and 7 days

Description: APACHE II is a prognostic score based on 12 different items obtained in the first 24 hours of ICU admission. Its mainly used as a single measure, but some authors have used and described prediction usefulness with repeated measures. It ranges from 0 to 71 points. Higher scores are related to higher ICU mortality. The effect of WJ-MSC in the APACHE II score will compared between the two groups.

Measure: Difference in APACHE II score between groups

Time: Baseline and 7 days

Description: Evaluation of the effect of WJ-MSC in lymphocyte count measured in absolute number/mm3. These laboratory measures have been associated with COVID 19 severity.

Measure: Difference in lymphocyte count between groups